Autologous Stem Cell Media for Clinical Studies

Vitro offers various products to support use of autologous mesenchymal stem cells (MSCs) for clinical studies to advance understanding of the regenerative and therapeutic benefit of this type of adult stem cell. Use of a patient’s own stem cells for therapeutic benefit has numerous potential benefits including absence of immune rejection and minimal side effects. However, these therapies have yet to gain FDA approval while hematopoietic stem cell transplants have been FDA approved for treatment of a variety of blood cell cancers and autoimmune diseases for over 40 years.

Our products provide important tools to advance clinical studies of MSCs including chemically-defined and animal component-free media for growth & differentiation of MSCs, assays for quantitative measurement of MSC quality, potency (including prediction of transplantation efficacy) and response to toxic agents. Several reports indicate the need for substantial numbers of MSCs, usually several million, in order to achieve therapeutic benefit and this is accomplished by expansion of MSCs through culture of a patient’s MSCs in a laboratory followed by transplantation back into the patient often in the precise location of the required therapeutic benefit. However, such procedures may well influence the therapy and are thus considered by the US FDA as sufficient to shift the regulatory status of such cultured cells to that of a drug. Our products support additional development of cellular therapy based on MSCs by providing animal component-free and chemically-defined media for cellular expansion prior to therapy and well-validated assays for quantitative MSC potency determination, as required by regulatory agencies.

This figure shows growth of human MSCs in MSC-Gro™ media. We developed powdered formulations of our humanized and serum-free growth media. These dried formulations reduce the liquid volume requirements for shipping by 500-fold and the weight of each shipment is reduced approximately 70-fold resulting is substantial savings for product shipment, especially to offshore destinations. Our powdered formulations consist of a powdered component and a small-volume liquid supplement. Preparation of the complete medium by the end-user requires reconstitution in water-for-injection, highly purified water, prior to addition of the supplement concentrate and sterile filtration. We provide instructions for these procedures. This figure shows growth of human cord-blood MSCs in low serum and humanized complete MSCGro™ media. Also shown is MSC growth in our powdered humanized formulation after reconstitution. This growth was similar to complete media except when human serum was omitted. The lack of human serum slowed growth considerably and indicates the necessity of human serum addition to achieve growth rates comparable to our complete humanized medium. Our powdered humanized medium is offered without human serum and requires supplementation with human serum to achieve rapid growth. The human serum added may be either autologous or allogeneic for studies comparing autologous or allogeneic serum in clinical applications of MSCs, which is under active investigation.

This graph shows the real time stability of MSC-Gro™ and MSCM sold by ScienCell Laboratories. While cell growth slowed and MSCM ceased to support MSC growth at 3 months, MSC-Gro™ supported human MSC growth for over 12 months. Also, in addition to cord-blood MSCs, MSC-Gro™ also supported growth of adipose-derived human MSCs maintained at 20% O₂ for greater than 6 months. These results were provided by an independent third party and also corroborate the effectiveness of MSC-Gro™ at 20% O₂ using human adipose-derived MSCs. MSC low serum media provided by Lonza, InVitrogen and Stem Cell Technologies has real time stability of 1 month or less as stated within the package inserts provided with these products.

AUTOLOGOUS STEM CELL MEDIA PRODUCTS

SC00B4: Humanized mesenchymal stem cell clinical grade medium. Serum-free complete medium intended for additional supplementation by patient-specific serum for use as autologous, humanized and zeno-free medium for expansion of patient-specific MSCs. Catalog Number SC00B4-1, 500 ml bottle, store at 8℃, $125 USD/bottle. Catalog Number SC00B3-2, 100 ml bottle, store at 8℃, $45 USD/bottle.
Specifications:
• Sterility: Negative for organism growth & mycoplasma.
• Endotoxin level: <0.2 EU/ml.
• Performance: Achieves criterion human MSC growth; shelf-life: 180 days at 8℃.

SC00B6B: MSC chondrogenic differentiation medium based on humanized MSC medium without added human serum. Intended for additional supplementation with autologous human for the differentiation of MSCs to chondrocytes. Catalog Number SC00B6B-1, 500 ml bottle, store at 2 to 8oC, $250 USD/bottle. Catalog Number SC00B6B-2, 100 ml bottle, store at 8℃, $90 USD/bottle.
Specifications:
• Sterility: Negative for organism growth & mycoplasma.
• Endotoxin level: <0.2 EU/ml.
• Performance: Achieves criterion human MSC differentiation; shelf-life: 180 days at 8℃.

SC00B9B: MSC adipogenic differentiation medium based on humanized MSC medium. Intended for additional supplementation with autolgous human for the differentiation of MSCs to adipocytes. Catalog Number SC00B9B-1, 500 ml bottle, store at 2 to 8℃, $150 USD/bottle. Catalog Number SC00B9B-2, 100 ml bottle, store at 2 to 8℃, $50 USD/bottle.
Specifications:
• Sterility: Negative for organism growth & mycoplasma.
• Endotoxin level: <0.2 EU/ml.
• Performance: Achieves criterion human MSC differentiation; shelf-life: 180 days at 8℃.

SC00B12B: MSC osteogenic differentiation medium based on humanized MSC medium. Intended for additional supplementation with autologous human serum for the differentiation of MSCs to osteoblasts. Catalog Number SC00B12B-1, 500 ml bottle, store at 2 to 8oC, $170 USD/bottle. Catalog Number SC00B12B-2, 100 ml bottle, store at 2 to 8℃, $62 USD/bottle.
Specifications:
• Sterility: Negative for organism growth & mycoplasma.
• Endotoxin level: <0.2 EU/ml.
• Performance: Achieves criterion human MSC differentiation; shelf-life: 180 days at 2-8℃.

SC00B15: Humanized mesenchymal stem cell clinical grade medium, dried formulation. This serum-free medium requires reconstitution with WFI, addition of liquid concentrate supplement that is provided and addition of human serum that may be allogeneic or autologous. Catalog Number SC00B15, sufficient to prepare 10 Lt complete medium. $2000 USD/10 Lt. Store powder at 2 to 8℃ and supplement concentrate at -20℃.
Specifications:
• Sterility: Negative for organism growth & mycoplasma.
• Endotoxin level: <0.2 EU/ml.
• Performance: Achieves criterion human MSC growth; shelf-life: 180 days at 2-8℃ following reconstitution.

The LUMENESC™ assays provide quantitative assessment of stem cell quality, potency and response to toxic agents through the bioluminescent determination of cellular ATP content. This figure shows results of the analysis of human MSCs grown in different commercially available media.

The slope of the dose-response curves is directly related to potency of the MSCs while the normalized ATP concentration levels are a measure of stem cell quality. This shows the dose-response of human MSCs cultured in MSC-Gro™ compared to Stem Cell Technologies, Mesencult medium. Both potency and quality were greater in MSC-Gro™ and the differences were significant (p<0.05).

LUMENESCTM ASSAY PRODUCTS

KLMC-HHS96-1: Bioluminescent assay kit for quantitative determination of MSC quality, potency and response to toxic agents. Catalog Number KLMC-HHS96-1, 1 x 96 well microtiter plate & reagents based on humanized MSC medium. Store at 2 to 8℃ or -20℃. $350 USD/kit.

KLMC-HSF96-1: Bioluminescent assay kit for quantitative determination of MSC quality, potency and response to toxic agents. Catalog Number KLMC-HSF96-1, 1 x 96 well microtiter plate & reagents based on serum-free MSC medium. Store at 2 to 8℃ or -20℃. $350 USD/kit.

KLS-96-NA-1: Bioluminescent assay kit for quantitative determination of ESC, iPS and primary stem cell quality, potency and response to toxic agents. Catalog Number KLS-96-NA-1, 1 x 96 well microtiter plate & reagents for non-adherent cells. Store at 2 to 8℃ or -20℃. $315 USD/kit.

Additional information about the Lumenesc™ and other bioluminescent stem cell assays can be found at the HemoGenix, Inc. website, www.hemogenix.com. The Lumenesc™ assays are jointly manufactured by Vitro and our strategic partner, Hemogenix, Inc.